In 60 days, most insurers must cover HIV prevention drugs, related services with no cost-sharing

 The federal government issued guidance Monday stating that almost all health insurers must cover HIV prevention drugs — such as Gilead’s Truvada and Descovy — with no cost-sharing, as well as associated lab testing and follow-up visits.

Insurers were already required to quit charging out-of-pocket fees for the drugs, called HIV Preexposure Prophylaxis (PrEP), by January of this year. But now insurers have 60 days to comply with the additional requirements, including no-cost services like baseline and follow-up testing, as well as monitoring, according to the guidance.

The news comes about two years after the US Preventive Services Task Force granted an “A” rating to PrEP treatments, requiring clinicians to offer “effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition.”

Truvada was approved back in 2004 to treat HIV, and was sanctioned by the FDA as a preventative treatment in 2012. According to the CDC, daily PrEP reduces the risk of getting HIV via sexual intercourse by more than 90%.

AIDS activists, lawmakers and patients have criticized Gilead over the years regarding the price of Truvada, which cost nearly $2,000 for a one-month supply without insurance back in 2020. In May 2019, advocacy organization Health GAP testified to the US House committee on oversight and reform that generic versions in other countries were being sold for as little as $6 per month.

“While under-utilization of PrEP is caused by multiple factors, it is clear that price is a barrier that inhibits broad access,” the group said.

Gilead spent a priority review voucher to clear Descovy for PrEP back in 2019, just before Truvada generics were set to hit the market in 2020. Last year, Gilead’s HIV products raked in $16.9 billion, up 3% from 2019. Teva launched the first generic version of Truvada in October, charging $48.51 per tablet.

In November 2020, the HIV+Hepatitis Policy Institute reported that come 2021, “many plans” would not be in compliance with the legal requirement to offer PrEP treatment without cost-sharing, and urged insurers to take corrective action.

“The HIV community and public health leaders have been working for years to get to the day when insured people who are at risk of HIV can access PrEP without cost-sharing,” executive director Carl Schmid said at the time. “Unfortunately, it appears that some insurers and insurance regulators do not share our enthusiasm. I hope that will be corrected immediately.”

While PrEP will soon be readily available for insured patients, uninsured patients could still be left with no protection. According to an NBC News report, Gilead provides PrEP for free to lower-income people who aren’t insured, but it doesn’t cover associated services. And, safety net clinics are set to lose $100 million in annual HIV prevention funds due to a recent decision by Gilead.

https://endpts.com/in-60-days-most-insurers-will-be-required-to-cover-hiv-prevention-drugs-and-related-services-with-no-cost-sharing/